Interlude rolled tampons in plastic applicator are menstrual tampons used to absorb menstrual fluid. These tampons will be provided with 3 absorbencies - Regular, Super and Super Plus. These Tampons are rolled and made from organic cotton and polymeric overwrap in which a cotton cord is inserted. The applicator tubes are made of plant-based polyethylene and include a cylindrical barrel with finger grip and a one-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Interlude Rolled Tampons in Plastic Applicator. It outlines the device, its intended use, comparison to a predicate device, and performance testing conducted.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Performance Characteristic)	Reported Device Performance (K191431)
Dimensions	Met
Absorbency range (Syngyna Absorbency)	Regular: 6.0 - 9.0 gramsSuper: 9.0 - 12.0 gramsSuper Plus: 12.0 - 15.0 grams
Chemical residues	Met
Withdrawal cord strength	Met
Fiber shedding	Met
Tampon integrity	Met
Biocompatibility in accordance with ISO 10993 standards:
Cytotoxicity (MEM Elution Test)	Met requirements of ISO 10993-5:2009
Sensitization (Guinea Pig Maximization Test)	Met requirements of ISO 10993-10:2010 (R) 2014
Irritation (Vaginal Irritation Test)	Met requirements of ISO 10993-10:2010 (R) 2014
Acute Systemic Toxicity	Met requirements of ISO 10993-11:2006
Microbiology Testing (does not enhance growth of):
Staphylococcus aureus	Demonstrated not to enhance growth
Toxic Shock Syndrome Toxin-1 (TSST-1) production	Demonstrated not to increase production
Alteration of normal vaginal microflora	Demonstrated not to alter growth

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., dimensions, absorbency, chemical residues, biocompatibility, microbiology). However, it implies that the testing was conducted on samples of the "subject tampons and applicators." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, but it refers to testing performed on the final device product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing appears to be objective, lab-based performance and biocompatibility testing rather than expert-driven ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The tests are based on objective measurements against established standards and criteria, not on expert adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical device (tampon) and not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (tampon) and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance testing is based on:

Established standards and guidance documents: Specifically, the "2005 FDA guidance document 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff'" for performance characteristics and the "FDA guidance document 'Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process' issued in 2016 and ISO 10993 standards" for biocompatibility.
Objective laboratory measurements: For dimensions, absorbency, chemical residues, withdrawal cord strength, fiber shedding, tampon integrity, and microbiological growth.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, this is a physical medical device.

Summary

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October 7, 2019

ALBAAD fem c/o Robert Staab Official Correspondent Regulatory Technical Associates 30 Neck Road Old Lyme, CT 06371

Re: K191431

Trade/Device Name: Interlude Rolled Tampons in Plastic Applicator Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: August 30, 2019 Received: September 4, 2019

Dear Robert Staab:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Sharon Andrews Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191431

Device Name

Interlude Rolled Tampons in Plastic Applicator

Indications for Use (Describe)

Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K191431

1. Submitter Information

Applicant:	ALBAAD fem
Contact:	Shlomo Helvits
Address:	1, Alon Hatavor St.Caesarea Ind. Park 3088900Israel
Phone:	+972-4-6223860
Fax:	+972-4-6277022

2. Correspondent Information

Contact:	Robert. J. Staab
	Regulatory Technical Associates
Address:	30 Neck Road, Old Lyme, CT 06371 US
Phone:	+1 860-434-5872
Fax:	+1 860-434-5892
Email:	rta1ali1@aol.com

3. Date Prepared: October 01, 2019

4. Device Information

Device Name:	Interlude Rolled Tampons in Plastic Applicator
Common Name:	Unscented Menstrual Tampon
Regulation Number:	21 CFR 884.5470
Regulation Name:	Tampon, Menstrual, Unscented
Regulatory Class:	Class II
Product Code:	HEB

5. Predicate Device Information

The predicate device is Interlude and private label Unscented 3-piece compact applicator tampon (K173225). This predicate device has not been subject to a design-related recall.

6. Device Description

Regular size absorbency = 6 - 9 grams
Super-size absorbency= 9 12 grams ●
. Super plus size absorbency = 12 -15 grams

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7. Indications for Use

Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

	Subject Device (K191431)	Predicate Device (K173225)
Product Name	Interlude Rolled Tampon inPlastic Applicator	Interlude and private labelUnscented 3-piececompact applicator tampon
ClassificationRegulation	884.5470	884.5470
Product Code	HEB	HEB
Intended Use	Interlude rolledtampons in plasticapplicator are insertedinto the vagina andused to absorbmenstrual or othervaginal discharge.	Interlude and otherprivate label unscented3-piece compactapplicator tampons areinserted into the vaginaand used to absorbmenstrual or othervaginal discharge.
Sterile?	No	No
Design	Compact styleapplicator withcylindrical barrel withfinger grip and one-piece plunger. Digitaltampon with round tipand straight grooves.	Compact styleapplicator withcylindrical barrel withfinger grip and two-piece plunger. Digitaltampon with round tipand straight grooves.
Syngyna Absorbency(gram)	Regular 6.0 - 9.0Super 9.0 - 12.0Super plus 12.0 - 15.0	Regular 6.0 - 9.0Super 9.0 - 12.0NA
Pledget Length (mm)	46±2	46+2
Pledget Diameter(mm)	11±1, 14±1, 16±1	14±1, 16±1
Overwrapcomposition	PE/PES	PE/PES
Pledget composition	Organic cotton	Viscose rayon
Withdrawal cord	Organic cotton	Polyester cotton
Cord length	110-140 mm	110-130 mm
Applicator	LDPE	LDPE/HDPE barrel; PP pushers
Primary packaging	Polypropylene	Polypropylene

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

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The subject and predicate devices have intended use - to absorb menstrual or other discharge in the vagina. They have the same design and comparable dimensions and absorbencies. The differences in technological characteristics do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Performance testing

The following performance characteristics were assessed in accordance with the 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".

Dimensions ●
Absorbency range
Chemical residues
Withdrawal cord strength
Fiber shedding
Tampon integrity

Biocompatibility Testing

Biocompatibility studies were performed in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" issued in 2016 and ISO 10993 standards as follows:

Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009
. Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010 (R) 2014
Irritation (Vaginal Irritation Test) per ISO 10993-10:2010 (R) 2014 ●
Acute Systemic Toxicity per ISO 10993-11:2006 ●

These tests were performed on the subject tampons and applicators, and the results met the requirements of the ISO standards.

Microbiology Testing

Per the 2005 FDA guidance document mentioned above, microbiology testing was conducted to demonstrate that the subject devices do not:

Enhance the growth of Staphylococcus aureus
Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
Alter the growth of normal vaginal microflora

10. Conclusions

The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 884.5470 Unscented menstrual tampon.

(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).